celecoxib compared with no treatment before surgery in treating patients with localized prostate cancer

Conditions: Prostate Cancer

Summary: rationale: celecoxib may be an effective treatment for early stage prostate cancer. it is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer. purpose: randomized phase i trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.

objectives: * compare biomarker modulation (prostaglandin levels) in tissue samples of patients with localized prostate cancer treated with neoadjuvant celecoxib vs placebo followed by prostatectomy. * compare the effect of these regimens on angiogenic factors within the prostate in these patients. * determine the pharmacokinetic and pharmacodynamic effects of celecoxib in these patients. * compare the toxicity profiles of these regimens in these patients. * compare the compliance of patients treated with these regimens. outline: this is a randomized, double-blind, placebo-controlled study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral neoadjuvant celecoxib twice daily. * arm ii: patients receive oral neoadjuvant placebo twice daily. treatment in both arms continues for at least 4 weeks followed by prostatectomy. patients are followed within 1 month and then at 3 months. projected accrual: a total of 60-70 patients (at least 30 per arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed localized adenocarcinoma of the prostate with one or more of the following: * gleason sum at least 7 * prostate-specific antigen (psa) at least 15 ng/ml * clinical stage t2b or t2c (stage ii) * any combination of psa, clinical stage, or gleason sum with an estimated risk of capsular penetration greater than 45% * at least 3 positive core biopsies * planned radical prostatectomy * no metastatic disease secondary to prostate cancer patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * wbc greater than 3,000/mm\^3 * platelet count greater than 100,000/mm\^3 * hemoglobin greater than 9 g/dl * no history of bleeding disorders hepatic: * bilirubin less than 1.5 mg/dl * ast/alt less than 1.5 times upper limit of normal * no viral hepatitis renal: * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 50 ml/min other: * no history of hypersensitivity and/or adverse reactions to salicylates * no allergy to sulfa-containing medications * no other active malignancy within the past 5 years except superficial bladder cancer or nonmelanoma skin cancer * no medical or psychiatric problem that would preclude study participation * no active infection * hiv negative prior concurrent therapy: biologic therapy: * no prior immunologic therapy for prostate cancer chemotherapy: * at least 4 weeks since prior chemotherapy and recovered endocrine therapy: * no prior androgen ablation for prostate cancer * at least 4 weeks since prior hormonal therapy and recovered * at least 30 days since prior chronic use (more than 3 times per week for more than 2 weeks) of glucocorticoids * no concurrent glucocorticoids radiotherapy: * at least 4 weeks since prior radiotherapy to the pelvis or surrounding tissues and recovered surgery: * see disease characteristics * at least 4 weeks since prior major surgery and recovered other: * no prior investigational therapy for prostate cancer * no prior or concurrent chronic anticoagulants * no prior cyclo-oxygenase-2 inhibitor therapy (e.g., rofecoxib or celecoxib) * at least 4 weeks since prior initiation of vitamins (except multivitamin) or herbs with known effects on prostate function (psa) * at least 30 days since prior chronic use (more than 3 times per week for more than 2 weeks) of aspirin (greater than 100 mg/day) or non-steroidal anti-inflammatory drugs (nsaids) * at least 24 hours since prior use and no concurrent use of any of the following: * over-the-counter (otc) or prescription products containing aspirin or nsaids; otc products containing bismuth subsalicylate, sodium salicylate, and/or magnesium salicylate; choline salicylate; ranitidine; cimetidine; famotidine; or lansoprazole * no aspirin (100 mg/day) within 1 week prior to surgery * no concurrent addition of vitamins or herbal supplements

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer adenocarcinoma of the prostate